Medtronic has released the 2006 CRM Product Performance Report (volume 54), detailing current information about pacemaker, implantable cardioverter-defibrillator (ICD) and implantable lead performance products. Available online at www.CRMPPR.medtronic.com, it is being distributed to 27,000 physicians and provides Medtronic product performance information; explanation of statistical methods; distinct data for each device model; more information about types of device malfunctions detailing whether therapy function was compromised; and greater detail about estimated product life cycles, with charts showing the usual overall product survival rates (which include normal battery depletion), as well as malfunction-free product survival rates.
In addition, updates of recent product advisories are clearly highlighted at the front of the report with all other advisories linked to each affected device model.
Steve Mahle, executive vice president of Medtronic and president of Medtronic Cardiac Rhythm Management, commented: "This latest report continues to demonstrate that pacemakers and ICDs remain among the safest and most effective implantable devices. The life-saving and enhancing capabilities of our devices offer physicians and patients unique and proven ways to treat heart arrhythmias and sudden cardiac death."
With more than 65,000 pacemaker and ICD leads evaluated since the inception of its chronic lead studies at 35 centers worldwide, Medtronic claims it can provide physicians with a unique understanding of the performance of this critical part of the implantable system. The Medtronic CRM Product Performance Report is produced semi-annually to provide timely and reliable information on device performance to physicians. Data contained in the 2006 report are generated from analysis of returned products and post-market studies and are applicable to the more than 6.6 million total implanted devices and more than 3.4 million currently implanted (active) devices in the US. Medtronic strongly encourages the return of explanted devices to the company.
Lawsuit
However, in related news, Medtronic is facing a lawsuit alleging that it continued to sell flawed defibrillators for two years, despite knowing that some of them may suddenly stop working.
Medtronic issued the advisory note in February last year, saying there were nine reports of batteries shorting out in its cardioverter defibrillators and cardiac resynchronization therapy defibrillators. If the battery does short the device may stop working in as little time as a few hours. At that time, around 87,000 patients were implanted with the device. While 19,000 people have had surgery to replace the device, Medtronic says that no deaths have been linked to device failures.
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